ステージIII-IVまたは再発性子宮内膜がんにおける通常の化学療法（パクリタキセルおよびカルボプラチン）への免疫療法薬ペンブロリズマブの追加試験

基本情報

NCT ID: NCT03914612
ステータス: 実施中（募集終了）
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 813
治験依頼者名: National Cancer Institute (NCI)

概要

This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back after a period of improvement (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs is better or worse than the usual approach for treatment of this cancer.

対象疾患

Endometrial Clear Cell AdenocarcinomaEndometrial Dedifferentiated CarcinomaEndometrial Endometrioid AdenocarcinomaEndometrial Mixed Cell AdenocarcinomaEndometrial Serous AdenocarcinomaEndometrial Undifferentiated CarcinomaRecurrent Endometrial AdenocarcinomaRecurrent Endometrial CarcinomaRecurrent Endometrial Clear Cell AdenocarcinomaRecurrent Endometrial Dedifferentiated CarcinomaRecurrent Endometrial Endometrioid AdenocarcinomaRecurrent Endometrial Mixed Cell AdenocarcinomaRecurrent Endometrial Serous AdenocarcinomaRecurrent Endometrial Undifferentiated CarcinomaStage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

介入

Carboplatin(DRUG)

Computed Tomography(PROCEDURE)

Paclitaxel(DRUG)

Pembrolizumab(BIOLOGICAL)

Placebo Administration(OTHER)

Quality-of-Life Assessment(OTHER)

Questionnaire Administration(OTHER)

依頼者（Sponsor）

Canadian Cancer Trials Group(NETWORK)

National Cancer Institute (Nci)(NIH)

Nrg Oncology(OTHER)

実施施設 (4)

新潟大学医歯学総合病院

Niigata, Niigata, Japan

社会福祉法人恩賜財団済生会支部　広島県済生会　済生会呉病院

Kure, Hiroshima, Japan

埼玉医科大学国際医療センター

Saitama, Japan

愛媛大学医学部附属病院

Tōon, Ehime, Japan